Current Status of Treatment for Chinese Patients With ESR1-mutated HR+/HER2-advanced Breast Cancer
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Endocrine therapy, Chemotherapy Prednisone.
- Кому может быть актуально
- Состояния в реестре: ESR1 Gene Mutation, Advanced Breast Cancer. Базовые параметры: от 18 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Effectiveness and Safety of Different Treatment Regimens in Patients With ESR1-mutated HR+/HER2-advanced Breast Cancer After Failure of Prior Endocrine Therapy: a Prospective, Non-interventional, Real-world Study
Обзор
This is a prospective, non-interventional real-world study to observe the efficacy and safety of different treatment regimens in patients with ESR1-mutated HR+/HER2-advanced breast cancer after failure of endocrine therapy. Epidemiological data, efficacy and safety measures will be collected for each subject. Data on efficacy and safety assessment indicators will be collected every 2-3 months until disease progression, receipt of a new anti-tumour treatment modality, death, loss to follow-up, and arrival at the data collection cut-off date. The cut-off date for data collection is defined as 8 weeks after completion of 6 visits for each subject, or 4 weeks after treatment discontinuation and subject discontinuation/withdrawal. Subjects receiving a different treatment regimen remained subject to assessment of safety indicators 4 weeks after discontinuation of the original treatment regimen.
Вмешательства
- Препарат Endocrine therapy
All endocrine treatment regimens approved for advanced breast cancer, including tamoxifen, aromatase inhibitors, fulvestrant, etc. - Препарат Chemotherapy Prednisone
All chemotherapy treatment regimens approved for advanced breast cancer
Первичные конечные точки
- PFS [Срок оценки: 18 months]
Вторичные конечные точки (3)
- ORR [Срок оценки: 6 months]
- CBR [Срок оценки: 6 months]
- DoR [Срок оценки: 18 months]
Критерии участия
Критерии включения
- 1\. must have a histologically or cytologically confirmed diagnosis of breast cancer with evidence of locally advanced disease unsuitable for excision or radical radiotherapy, or evidence of metastatic disease unsuitable for radical treatment.
- 2\. female ≥ 18 years of age
- 3\. female subjects must be postmenopausal (meeting any of the following criteria is sufficient) a) Has undergone oophorectomy. b) Age ≥ 60 years. c) 40 years old < age ≤ 60 years old with 1 year of menopause. d) Age <60 years and receiving ovarian suppression therapy.
- 4\. ER-positive and HER2-negative status and ESR1-mutation positive must be confirmed.
- 5\. must have progressed on at least one line of endocrine therapy prior to enrollment, including monotherapy or combination therapy.
- 6\. have normal organ function (as assessed by the investigator).
Критерии исключения
- 1\. women who are pregnant or breastfeeding
- 2\. known difficulties in tolerating oral medications, or conditions that interfere with the absorption of oral medications or allergies to medications and their excitements
- 3\. other conditions that make enrollment in the study unsuitable, at the discretion of the investigator
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Китай · 1 центр
- Tianjin Haidafu Internet Hospital — Сучжоу
Идентификаторы
NCT: NCT06548919 · ABC-RWS-02